NCT02467790

Polyethylene Glycol Loxenatide Pharmacokinetics Study in Subjects With Normal and Insufficiency Renal Function

Kinetic Study of Human Pharmacokinetics in Normal Renal Function, and Renal Insufficiency Subject of Polyethylene Glycol Loxenatide (PEX168)(Open, Non-randomized, Parallel-group)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 31 Years – 65 Years
• Healthy volunteers: Accepted

Summary

To compare and analysis pharmacokinetics of PEX 168 in patients with renal insufficiency or normal renal function who were administrated subcutaneously single dose PEX168.To evaluate dose adjustment of PEX168 administered in patients with renal insufficiency and provide a scientific basis in patients with renal insufficiency of rational drug use.

Detailed description

This is an open, non-randomized, parallel-group, single-dose study that evaluated the pharmacokinetics of PEX168 when single dose administered with PEX168 in patients with renal insufficiency and normal renal function subjects. The total duration of each subject's participation in the study was approximately 45 days, which included up to a 14-day Screening Period, a 31-day PK sample collecting Period. Center: This study was conducted at two sites in the Third Xiangya hospital of Center South University and Shanghai Changhai Hospital.All subjects receives a single 200μg doses of PEX168 injected subcutaneously on Day 1.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	PEX168	PEX 168: 200µg,Subcutaneous,one time.

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-03-01
• Completion: 2016-05-01
• First posted: 2015-06-10
• Last updated: 2016-01-26

Locations

1 site across 1 country: China